UMIN-CTR Clinical Trial

Basic information
Public title	Blood flow visualization by indocyanine green (ICG) fluorescence imaging of the reconstructed substitute after the resection of esophageal cancer
Acronym	ICG fluorescence blood flow visualization of the reconstructed substitute after esophageal cancer surgery
Scientific Title	Blood flow visualization by indocyanine green (ICG) fluorescence imaging of the reconstructed substitute after the resection of esophageal cancer
Scientific Title:Acronym	ICG fluorescence blood flow visualization of the reconstructed substitute after esophageal cancer surgery
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to evaluate the clinical utility of indocyanine green(ICG) fluoresence imaging for the assessment of blood flow of reconstructed substitute after esophageal cancer surgery.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase I

Assessment
Primary outcomes	Blood supply and microvessel network of reconstructed substitite by using ICG fluoresence.
Key secondary outcomes	Incidence of anastomotic leaks and other adverse events. Post operative length of stay.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Patients with esophageal cancer who plan for the elective surgeries (2)Patients with signed Informed consent
Key exclusion criteria	(1)Patients with impaired judgement (2)Patients with hypersensitivity to ICG (3)Patients with hypersensitivity to iodine
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Soji Middle name Last name Ozawa
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Email	sozawa@tokai.ac.jp

Public contact
1st name of contact person	1st name Soji Middle name Last name Ozawa
Organization	Tokai University School of Medicine
Division name	Department of Gastroenterological Surgery
Zip code	259-1193
Address	143 Shimokasuya, Isehara, Kanagawa
TEL	0463-93-1121
Homepage URL
Email	tokai.eso@tokai-u.jp

Sponsor
Institute	Tokai University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board for Clinical Research, Tokai University Hospital
Address	143 Shimokasuya, Isehara City, Kanagawa
Tel	0463931121
Email	tokai-rinsho@ml.tokai-u.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東海大学医学部付属病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2013 Year 12 Month 25 Day
Date of IRB	2013 Year 11 Month 29 Day
Anticipated trial start date	2013 Year 12 Month 25 Day
Last follow-up date	2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Following contents of the reconstructed substitute are observed during the esophageal cancer surgery. 1. Macroscopic blood flow observation of the reconstructed substitute before esophageal anastomosis. 2. Blood flow visualization by ICG fluorescence imaging of the reconstructed substitute before esophageal anastomosis. 3. Macroscopic blood flow observation of the anastomotic part and reconstructed substitute after esophageal anastomosis. 4. Blood flow visualization by ICG fluorescence imaging of the anastomotic part and reconstructed substitute after esophageal anastomosis. 5. Incidence of anastomotic leak and other major complications.

Management information
Registered date	2018 Year 03 Month 20 Day
Last modified on	2019 Year 03 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015543